USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices

Laurus Labs Ltd., a leading research and development driven pharmaceutical and biotech company in India, has announced the successful completion of the US Food and Drug Administration (USFDA) audit of its API manufacturing facility at Hyderabad. The audit concluded with zero Form 483 observations, reaffirming Laurus Labs commitment to maintaining the highest standards of quality, safety, and compliance.

The USFDA inspection, conducted from 9th to 13th September, focused on evaluating the facility's adherence to global regulatory requirements and best practices.

Laurus Labs' API manufacturing facility, located at DS-1, IKP Knowledge Park, Genome Valley, Shameerpet, Telangana is instrumental in developing Active Pharmaceutical Ingredients, bolstering the company's ability to deliver high-quality, innovative pharmaceutical solutions to its global customers.